In this webinar, you will learn how to optimize your CAPA program by clearly defining the problem, and understanding what questions to ask to identify the root cause of the problem.

1. FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
Optimizing Your CAPAs
Maximize Your Efforts with an Effective Process
Ranjeet Klair
Director of Food Safety, The Acheson Group- TAG
March 25, 2022

2. Monthly Industry Update:
✔FSMA Related News
✔Regulation Changes & Updates
✔Industry Trends
✔Q&A with TAG
What is FSMA Fridays?
FSMA FRIDAYS

3. Casual but Professional Format
✔Ask questions! (Q&A at end)
✔Only panelists are displayed
✔Recording link will be shared
✔Audio issues: use call-in number
Watch prior FSMA Friday recordings at
safetychain.com > Resources > FSMA Fridays
Before We Get Started
FSMA FRIDAYS

4. Featured FSMA Friday Speaker & Host
FSMA FRIDAYS
Aaron Bolshaw
CMO
Moderator for Beyond
Compliance and FSMA
Fridays
Ranjeet Klair
Director, Food Safety
Ranjeet Klair, Senior Advisor, Food Safety, has 20 + years of industry
experience.
● Ranjeet has worked with Canadian, US, and global food
retailers, production plants, and certification bodies in food
safety, quality assurance, and regulatory compliance.
● Ranjeet holds a Master of Science degree in Food Sciences,
Master of Global Food Law (Jurisprudence) degree, and a
Bachelor of Applied Science and certification in International
Food Laws and Regulations. Along with completing a
Certification program for International Food Laws and
Regulations.
● Ranjeet has held roles as Senior Manager of Food Safety and
QA where she implemented a Food Safety Quality Management
System under FSEP program CFIA, and wrote and implemented
BRC issue 6 standard for the plant.

5. FSMA FRIDAYS
1. Agricultural Water Assessment Builder.Tool prompts users to answer questions specific to their unique conditions. Read
the disclaimer!
2. GMP, Preventive Controls, FSVP, IA, Produce Safety - guidance issued
3. Revised guidance for Voluntary Qualified Importer program
4. Seafood processors are subject to some of the rules of FSMA in addition to regulated under FDA through the Seafood
HACCP regulation (21 CFR part 123)
5. FDA issued new guidance on its intent not to enforce certain provisions of five rules of FSMA. TAG has further reviewed
the guidance and interpreted as the enforcement discretion notice means that FDA intends to not enforce specific
provisions of certain rules “as they currently apply to entities or activities addressed in the guidance” while FDA “take(s)
time to consider options, including rulemaking, to address concerns raised by stakeholders.”
FSMA Updates

6. FSMA PC rule and CAPA
FSMA FRIDAYS
FSMA PC rule of Human foods 21 CFR 117 Subpart C - Hazard Analysis
and Risk-Based Preventive Controls part 117.150-117.165
Key steps in Regulation:
● corrective action and corrections
● verification and validation
● verification of implementation and effectiveness

7. FSMA Definitions in PC Rule for Human Foods
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Corrective Action
Procedures that must be taken if
preventive controls are not
properly implemented.
from 21 CFR 117.150(a)(1)
Correction
An action to identify and correct
a problem that occurred during
the production of food, without
other actions associated with a
corrective action procedure
(such as actions to reduce the
likelihood that the problem will
recur, evaluate all affected food
for safety, and prevent affected
food from entering commerce).
21 CFR 117.3

8. RCA-CAPA(What and Why)
FSMA FRIDAYS
● The root cause is the original source of a reason of the incident
● RCA consists of where, when and how the incident occurred
● RCA investigator must be aware of the processing steps
● A successful RCA will allow development of appropriate corrective action
● Prevent recurrence of the deviation Identify the root cause(s)

9. Commonly Used Tools for RCA
FSMA FRIDAYS
● Brainstorming
● Five Why’s
● Fishbone or Ishikawa Diagram
● KNOT Chart
● Pareto Charts
● Fault Tree Analysis
● Failure Mode and Effects Analysis (FMEA)

10. Food Safety Investigation Starts with RCA
FSMA FRIDAYS
Core steps of capacity development for RCA
• Food Safety
Investigation
• Identify Root Cause
• Identify Corrective
Action
• Implement Preventive
Action

11. Food Safety Investigations
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Drivers:
• Internal company findings (Internal audits, inspections, FS
Deviations, QA, Micro results)
• Customer and consumer complaints
• Supplier issues
• Public health authorities investigating illnesses
• Food inspection regulators (surveys and complaints)

12. RCA & CAPA (How)
FSMA FRIDAYS
• A competent Lead Investigator and cross functional
RCA team
• The Lead Investigator will verify that the team has
“Followed the suspect food”.
• RCA investigator must be aware of the processing
steps

13. Leading Steps of a Successful CAPA
FSMA FRIDAYS
Process
● Immediate process
update/modifications
● Production stop when
deviation identified
● Apply alternate process
● Equipment
repair/recalibration
● Employees retraining
● Evaluate operation
Product
● Hold product
● Evaluate product
● Product testing
● Determine product
disposition
● Release, rework or destroy
product

14. Challenges
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What are the reasons of an ineffective CAPA?
• time-and resource-intensive
• Staff’s unwillingness to participate, interprofessional
differences, lack of time
• Leadership commitment
• Necessary skills and ability to investigate beyond initial
hypothesis to identify root cause

15. Initial Hypothesis of Root Cause and Corrective action
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Majority of CAPA reports show the following conclusions:
● Lack of staff training
● The issue was not found to be originated from the facility
● Original product/package was not received from the customer
● Relevant manager was notified
● No issues noted
● Training completed

16. Example of Inadequate CAPA
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● Situation: Rodent issue noted in shipping area
● Correction: Pest control operator company was notified
● Root cause reported by PCO: A hole in the south wall
leading to rodent entry in the facility
● Corrective action noted in CAPA: Maintenance manager
was notified
● CAPA: Closed

17. Inadequate CAPA: Rodent Issue Example
FSMA FRIDAYS
● CAPA was closed by notifying maintenance manager
● Missing part was lack of further follow up with maintenance
manager, review of work order, confirmation of completion
● The issue was closed in document but, the hole in the wall
and risk of rodent was not addressed.

18. RCA, CA-PA Of Missing Hairnet Situation
FSMA FRIDAYS
Initial hypothesis: Lack of staff training
• Missing Hairnet situation
• Hair net was not worn properly
Training completed, documented.
Repeat of same Issue:
• Missing Hairnet situation
• Hair net was not worn properly
RCA: With in-depth investigation revealed
Supply issues of hairnets from the supplier
CA: Finding alternate supplier of hairnet,
maintain inventory of hairnet to ensure
adequate supply of hairnets
PA: Daily, weekly inspections,
training, supplier
management

19. To Lead an Effective CAPA
FSMA FRIDAYS
Conducting Preliminary steps
● Assemble RCA CAPA team
● Data gathering for RCA should begin as early as possible
following the incident when critical evidence can be secured
○ Remove contaminated product from the marketplace
○ Assign the lead investigator
● Assign the team with specific role in the
● Food Safety investigation

20. Factors to Determine the Scope
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To understand the scope of RCA-CAPA for a food safety investigation:
● Food safety investigation findings
● Results of laboratory analysis (Period covered by the sampling)
● Production records
● Formulation
● Any changes in supply of materials
● Any changes in equipment
● Any climatic changes
● History of conformity
● The rapidity of sale of a food
● Epidemiological data

21. Factors to Determine the Scope
FSMA FRIDAYS
Consider every possible area of Plant Schematic

22. Factors to Determine the Scope
FSMA FRIDAYS
Consider every step of processing
step of HACCP Flow Chart
E.g. Microbiological contamination of cooked
product doesn’t necessarily a failure at
cooking step.

23. If CAPA is Leading to Address Any of the Following:
FSMA FRIDAYS
● Employee practices
● Improper sanitation and maintenance
● Inadequate cross contamination controls (process flow, plant
schematic/layout)
● Improper processing
● Incoming materials
● Environmental factors(seasonality, humidity)

24. Importance of Documentation
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Document review/record review for:
● direct observations
● inspection findings related to the suspect food
● Record review will help determine if the suspect food was made under normal
conditions
● Record review identify any limitations in the management system.

25. Known Limitations to Achieve Effective CAPAs
FSMA FRIDAYS
Records:
● A perfect record with no deviation in process since past many months /years is not
good news.
● Check the trends of filling records, use of same pen, same marking of checkmarks
may be completed in no real time.
Lack of Follow up:
● E.g., Notified maintenance manager but no follow up
Denial:
● the origin of non conformance was found to be originated from our facility.

26. CAPA Checkpoints
FSMA FRIDAYS
● Is it effective?
● How do we do effectiveness check?
● Document verification activities
● Data tracking post CAPA implemented
● Trend Analysis
● Communication

27. Maximize Your Efforts with an Effective CAPA
FSMA FRIDAYS
● Do talk about RCA CAPA tracking updates in Food Safety meetings
● Schedule onsite review of CAPA in specific time interval (30-60-90
days)
● Conduct vertical audits of the FSMS (pick a date or a lot of production
from past few months ago, review the records, verify if all process steps
were followed as per HACCP, PC process flow
● Recognize lead investigators and CAPA team

28. Key Elements for an Effective CAPA
FSMA FRIDAYS
● Organized team with documented decisions
● Strong team leadership
● Strong support from senior management (people, resources)
● CAPA team competency with ability to perform end-to-end RCA and CAPA
● Traceability systems
● Analytical capacity (internal and external)
● Dedicated liaison function
● Data capture, analysis and documentation of investigation
● Effective Corrective Action Preventive Action
● Ongoing monitoring

29. Q & A
FSMA FRIDAY

30. ✔ FSMA Friday Session Recordings & Content Library
✔ TAG Newsletter
✔ Global Food Safety Consultants
AchesonGroup.com
✔ FSMA Friday LinkedIn Group
✔ Q&A, Articles & Updates … Join FSMA FRIDAYS!
Resources & Future Events
FSMA FRIDAYS
Apr 5, 2022: Measuring the Real Cost of Quality: Methods, Models & Tips
Apr 20, 2022: Understand SPC Fundamentals